Global Patient Safety Business Excellence, Senior Manager
New
A
AmgenPharmacovigilance, life sciences
Source API remote eligibility restrictions: United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Doctorate degree & 2 years of Safety Project Management experience; Master’s degree & 4 years; Bachelor’s degree & 6 years; Associate’s degree & 10 years; or high school diploma / GED & 12 years.
- Required Skills
- Project ManagementChange Management
Requirements
- Doctorate degree and 2 years of Safety Project Management experience; or
- Master’s degree and 4 years of Safety Project Management experience; or
- Bachelor’s degree and 6 years of Safety Project Management experience; or
- Associate’s degree and 10 years of Safety Project Management experience; or
- High school diploma / GED and 12 years of Safety Project Management experience.
- Demonstrated expertise in project management, change management, and organizational transformation.
- Ability to understand pharmacovigilance regulations and compliance practices and interpret requirements into clear instructions.
- Significant experience in pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions.
- Experience establishing governance frameworks and leading complex, enterprise-wide initiatives.
- Experience leading process improvement using Lean, Six Sigma, Agile, or similar methodologies.
- Preferred: PMP certification or equivalent in Change or Project Management.
- Preferred: experience with mergers, acquisitions, and divestitures in Life Sciences.
Responsibilities
- Lead development and continuous improvement of project management and change management standards and methodologies across Global Patient Safety.
- Drive GPS governance frameworks and support effective oversight, decision-making, and alignment with organizational objectives.
- Lead business-critical GPS initiatives and represent GPS on enterprise-wide cross-functional programs.
- Provide oversight for pharmacovigilance activities related to mergers, acquisitions, licensing agreements, and divestitures.
- Advance the GPS Quality Management System and support compliance with global regulatory requirements.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness.
- Support Health Authority inspections, Business Partner audits, and Internal Process Audits.
- Develop, monitor, and report performance and compliance metrics for management review and decision-making.
- Facilitate management of deviations, CAPAs, and quality improvement initiatives.
- Champion adoption of automation, analytics, and emerging technologies in Global Patient Safety.
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